Alembic Pharma gets USFDA nod for 2 generic products

The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.

PTI

April 22, 2019, 14:03 IST

New Delhi: Drug firm Alembic Pharmaceuticals Monday said it has received approvals from the US health regulator for its Teriflunomide tablets and Tobramycin ophthalmic solution. The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Teriflunomide tablets in the strengths of 7 mg and 14 mg, Alembic Pharmaceuticals said in a filing to BSE.

The product is generic version of Sanofi-Aventis US LLC's Aubagio tablets in the same strengths, it added.

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